Intraoperative HypotensionHDA-USENCT05101590
Hypotension Decision Assist - Use, Safety and Efficacy
A study testing Monitored by HDA in people with Intraoperative Hypotension, run by Directed Systems Limited at 1 site in United Kingdom.
Trial summary
This clinical investigation will investigate whether Hypotension Decision Assist (HDA) is a feasible, safe and effective patient clinical decision support system to enhance an anaesthetist's ability to manage a patient's cardiovascular system when undergoing surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraoperative Hypotension
- What is being tested?
- Monitored by HDA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Oct 2021to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥18 years) due to undergo elective surgery who are likely to have an arterial line sited as part of their standard intraoperative care.
- Recruitment after booking for surgery with sufficient time to read, understand and question study patient information prior to attending for surgery.
- Ability and willingness to provide informed consent
- Expected duration of anaesthesia > 60 minutes
- Intra-arterial monitoring is part of routine clinical care
Who cannot join
- Inability to provide informed consent
- No arterial line planned as part of their intraoperative care
- Aged < 18 years of age
- Patients with aortic regurgitation
- Patients fitted with an intra-aortic balloon pump (IABP)
- No other intra-arterial pressure management system in use
- Concurrent participation in another experimental intervention or drug study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study of the Use, Safety and Efficacy of the Hypotension Decision Assist Device
This clinical investigation will investigate whether Hypotension Decision Assist (HDA) is a feasible, safe and effective patient clinical decision support system to enhance an anaesthetist's ability to manage a patient's cardiovascular system when undergoing surgery. If successful, this study will provide evidence that the use of HDA facilitates beneficial outcomes for patients who have this device used.
Read the detailed description
In this study participants who are due to undergo elective major surgery and have an arterial line as part of their standard care will be invited to have the additional monitoring device (HDA) included as part of their care. Agreeing participants will have demographic, contact and medical history information necessary to conduct the study recorded, including a record of their intraoperative arterial line measurements.
After completing the consent process participants will receive intraoperative monitoring with Hypotension Decision Assist in addition to their standard care. The HDA monitor will be attached to the patient vital signs monitor, which will in turn be attached to the blood pressure transducer. All sampled arterial line data collected by the patient vital signs monitored will be automatically transmitted in real time to the HDA device via a serial cable attached to a digital export port of the vital signs monitor. HDA will process this input data to display, in graphical and numeric format, vital signs data and physiological parameters derived from the arterial wave form data including: Mean Arterial Pressure (MAP), systolic and diastolic blood pressure, heart rate and changes in heart rate, cardiac output and systemic vascular resistance.
The output from the study will be compared to the primary and secondary outcomes to evaluate the performance and safety of the device and to evaluate whether HDA improves control of the cardiovascular system from the anaesthetists' perspective.
- Conditions
- Intraoperative Hypotension
- Being tested
- Monitored by HDA
- Keywords
- Hypotension, Intraoperative care, Intraoperative complications
- Medical subject headings
- Hypotension, Intraoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitored by HDADevice
Participants undergoing elective major surgery with an arterial line as part of their standard care and additional monitoring with HDA as part of their care.
| Study group | Role | What they receive |
|---|---|---|
| Monitored with HDA | Experimental | Participants undergoing elective major surgery and have an arterial line as part of their standard care with HDA included as part of their care Receives: Device: Monitored by HDA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Display of trends in mean arterial pressure measured in millimetres of mercury (mmHg)
Operative time were HDA derives and displays mean arterial pressure (mmHg) data that is relevant to the management of the blood pressure, hemodynamic stability and the cardiovascular system of the patient.
Measured: Intraoperative
Display of trends in systolic blood pressure measured in millimetres of mercury (mmHg)
Operative time were HDA derives and displays systolic blood pressure (mmHg) data that is relevant to the management of the blood pressure, hemodynamic stability and the cardiovascular system of the patient.
Measured: Intraoperative
Display of trends in diastolic blood pressure measured in millimetres of mercury (mmHg)
Operative time were HDA derives and displays diastolic blood pressure (mmHg) data that is relevant to the management of the blood pressure, hemodynamic stability and the cardiovascular system of the patient.
Measured: Intraoperative
Display of trends in heart rate measured in beats per minute (bpm)
Operative time were HDA derives and displays heart rate (bpm) data that is relevant to the management of the blood pressure, hemodynamic stability and the cardiovascular system of the patient.
Measured: Intraoperative
Display of trends of changes in heart rate (percentage) over the previous five minutes measured as a percentage
Operative time were HDA derives and displays changes in heart rate (percentage) data that is relevant to the management of the blood pressure, hemodynamic stability and the cardiovascular system of the patient.
Measured: Intraoperative
Display of trends of changes in cardiac output (percentage) over the previous five minutes measured as a percentage
Operative time were HDA derives and displays changes in cardiac output (percentage) data that is relevant to the management of the blood pressure, hemodynamic stability and the cardiovascular system of the patient.
Measured: Intraoperative
Display of trends of changes in systemic vascular resistance (percentage) over the previous five minutes measured as a percentage
Operative time were HDA derives and displays changes in systemic vascular resistance (percentage) data that is relevant to the management of the blood pressure, hemodynamic stability and the cardiovascular system of the patient.
Measured: Intraoperative
Adverse events (AEs) related to blood pressure attributable to HDA
Incidence, severity and causality of all AEs with delineation of those that are attributable to the use of HDA
Measured: Intraoperative
Secondary outcomes (4)
Measurement of intraoperative hypotension
Measured incidence of Mean Arterial Pressure < 65 for at least 1 minute
Measured: Intraoperative
Number and type of intervention made by anaesthetists
Quantification of interventions related to patient cardiovascular management including fluid administered, cardiovascular active drugs administered and or drug infusion rate changes if applicable
Measured: Intraoperative
Comparison of HDA projected trend feature
Comparison of the estimated MAP at +2mins by projected trend feature versus the observed Mean Arterial Pressure at that time as it arises.
Measured: Intraoperative
Anaesthetists evaluation of use against a five point Likert-type scale
Anaesthetists evaluation of the ease of use and usefulness of HDA ranked in accordance with a five-point Likert-type rating scale where the minimum value is 1 (strongly disagree that HDA is useful or easy to use) and the maximum is 5 (strongly agree that HDA is useful or easy to use) .
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start22 Oct 2021
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Monitored with HDA
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Directed Systems Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital Birmingham NHS Foundation Trust, Innovate UK
- Responsible party
- Sponsor
- Investigators
- Thomas Clutton-Brock, Principal investigator, University Hospital Birmingham NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05101590
- Sponsor's protocol ID
- BPA-CIP-001
- Acronym
- HDA-USE
- Status last verified
- Mar 2022
- First submitted
- 1 Oct 2021
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Use, Safety and Efficacy of the Hypotension Decision Assist Device
- ClinicalTrials.gov ID
- NCT05101590
- Acronym / sponsor ID
- HDA-USE / BPA-CIP-001
- Conditions
- Intraoperative Hypotension
- Keywords
- Hypotension, Intraoperative care, Intraoperative complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Directed Systems LimitedIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital Birmingham NHS Foundation Trust, Innovate UK
- Study start
- 22 Oct 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 1 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical investigation will investigate whether Hypotension Decision Assist (HDA) is a feasible, safe and effective patient clinical decision support system to enhance an anaesthetist's ability to manage a patient's cardiovascular system when undergoing surgery. If successful, this study will provide evidence that the use of HDA facilitates beneficial outcomes for patients who have this device used.
Detailed description
In this study participants who are due to undergo elective major surgery and have an arterial line as part of their standard care will be invited to have the additional monitoring device (HDA) included as part of their care. Agreeing participants will have demographic, contact and medical history information necessary to conduct the study recorded, including a record of their intraoperative arterial line measurements.
After completing the consent process participants will receive intraoperative monitoring with Hypotension Decision Assist in addition to their standard care. The HDA monitor will be attached to the patient vital signs monitor, which will in turn be attached to the blood pressure transducer. All sampled arterial line data collected by the patient vital signs monitored will be automatically transmitted in real time to the HDA device via a serial cable attached to a digital export port of the vital signs monitor. HDA will process this input data to display, in graphical and numeric format, vital signs data and physiological parameters derived from the arterial wave form data including: Mean Arterial Pressure (MAP), systolic and diastolic blood pressure, heart rate and changes in heart rate, cardiac output and systemic vascular resistance.
The output from the study will be compared to the primary and secondary outcomes to evaluate the performance and safety of the device and to evaluate whether HDA improves control of the cardiovascular system from the anaesthetists' perspective.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Monitored with HDA
| Arm | Type | Receives |
|---|---|---|
| Monitored with HDA | Experimental | Device: Monitored by HDAParticipants undergoing elective major surgery and have an arterial line as part of their standard care with HDA included as part of their care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults (≥18 years) due to undergo elective surgery who are likely to have an arterial line sited as part of their standard intraoperative care.
- Recruitment after booking for surgery with sufficient time to read, understand and question study patient information prior to attending for surgery.
- Ability and willingness to provide informed consent
- Expected duration of anaesthesia > 60 minutes
- Intra-arterial monitoring is part of routine clinical care
Key exclusion criteria (7 listed)
- Inability to provide informed consent
- No arterial line planned as part of their intraoperative care
- Aged < 18 years of age
- Patients with aortic regurgitation
- Patients fitted with an intra-aortic balloon pump (IABP)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monitored by HDAParticipants undergoing elective major surgery with an arterial line as part of their standard care and additional monitoring with HDA as part of their care. | Device | Monitored with HDA |
Primary outcome
Display of trends in mean arterial pressure measured in millimetres of mercury (mmHg)
Time frame: Intraoperative
Operative time were HDA derives and displays mean arterial pressure (mmHg) data that is relevant to the management of the blood pressure, hemodynamic stability and the cardiovascular system of the patient.
Display of trends in systolic blood pressure measured in millimetres of mercury (mmHg)
Time frame: Intraoperative
Operative time were HDA derives and displays systolic blood pressure (mmHg) data that is relevant to the management of the blood pressure, hemodynamic stability and the cardiovascular system of the patient.
Display of trends in diastolic blood pressure measured in millimetres of mercury (mmHg)
Time frame: Intraoperative
Operative time were HDA derives and displays diastolic blood pressure (mmHg) data that is relevant to the management of the blood pressure, hemodynamic stability and the cardiovascular system of the patient.
Display of trends in heart rate measured in beats per minute (bpm)
Time frame: Intraoperative
Operative time were HDA derives and displays heart rate (bpm) data that is relevant to the management of the blood pressure, hemodynamic stability and the cardiovascular system of the patient.
Display of trends of changes in heart rate (percentage) over the previous five minutes measured as a percentage
Time frame: Intraoperative
Operative time were HDA derives and displays changes in heart rate (percentage) data that is relevant to the management of the blood pressure, hemodynamic stability and the cardiovascular system of the patient.
Display of trends of changes in cardiac output (percentage) over the previous five minutes measured as a percentage
Time frame: Intraoperative
Operative time were HDA derives and displays changes in cardiac output (percentage) data that is relevant to the management of the blood pressure, hemodynamic stability and the cardiovascular system of the patient.
Display of trends of changes in systemic vascular resistance (percentage) over the previous five minutes measured as a percentage
Time frame: Intraoperative
Operative time were HDA derives and displays changes in systemic vascular resistance (percentage) data that is relevant to the management of the blood pressure, hemodynamic stability and the cardiovascular system of the patient.
Adverse events (AEs) related to blood pressure attributable to HDA
Time frame: Intraoperative
Incidence, severity and causality of all AEs with delineation of those that are attributable to the use of HDA
4 secondary outcomes
Measurement of intraoperative hypotension
Time frame: Intraoperative
Number and type of intervention made by anaesthetists
Time frame: Intraoperative
Comparison of HDA projected trend feature
Time frame: Intraoperative
Anaesthetists evaluation of use against a five point Likert-type scale
Time frame: Intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Clutton-Brock principal investigator
University Hospital Birmingham NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monitored by HDA in people with Intraoperative Hypotension, run by Directed Systems Limited at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Display of trends in mean arterial pressure measured in millimetres of mercury (mmHg) (time frame: Intraoperative). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.